AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management systems and patient medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.

AlertWatch:OR is also intended for use by supervising anesthesiologists outside of operating rooms. Once alerted, the supervising anesthesiologist must contact the clinician inside the operating room or must return to the operating room before making a clinical decision. Once either clinician is alerted, they must refer to the primary monitor or device before making a clinical decision.

Device Description

AlertWatch:OR is a display and secondary alert system used by the anesthesiology staff residents. CRNA's, and attending anesthesiologists - to monitor patients in operating rooms. The purpose of the program is to synthesize a wide range of patient data and inform clinicians of potential problems that might lead to immediate or long-term complications. Once alerted, the clinician is instructed to refer to the primary monitoring device before making a clinical decision. AlertWatch:OR should only be connected to AIMS systems and physiologic monitors that have been validated for use with AlertWatch:OR. AlertWatch, LLC performs the validation for each installation site.

The purpose of this 510(k) is for marketing clearance of AlertWatch:OR 2.50 which includes minor modifications to some display views, user features, indicators and alerts as well as compatibility with the iPad and the iPhone.

AI/ML Overview

The provided text is a 510(k) summary for the medical device AlertWatch:OR, focusing on its substantial equivalence to a previously cleared device. The "Performance Data" section discusses a human factors study and the process for establishing default limits and thresholds, but it does not describe an in-depth study with quantitative acceptance criteria for device performance in detecting or alerting.

Specifically, the document does not contain a table of acceptance criteria and reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity, accuracy). It focuses more on usability and the validation of alert thresholds as part of its performance data.

Therefore, many of the requested details about a study proving the device meets acceptance criteria are not present in this document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document refers to the validation of default limits and thresholds and a human factors study, but not quantitative performance criteria for the device's alerting function.

2. Sample Size for Test Set and Data Provenance

Human Factors Study: The text mentions a "comprehensive human factors study" for the iPhone version. It does not specify the sample size of users or the provenance of the data used in this study (e.g., retrospective/prospective, country of origin).
Default Limits and Thresholds: The validation of these limits involved "Review of References," an "Expert Committee" (anesthesia physicians at the University of Michigan Health System), and "External Experts" (four anesthesiology experts). This is not a "test set" in the traditional sense of evaluating device performance on patient data, but rather a process for establishing system parameters.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Human Factors Study: Not specified.
Default Limits and Thresholds:
- Expert Committee: An unspecified number of "anesthesia physicians at the University of Michigan Health System." Their specific qualifications beyond being "anesthesia physicians" are not detailed (e.g., years of experience).
- External Experts: Four "anesthesiology experts." Specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable as a traditional "test set" with adjudicated ground truth for diagnostic performance is not described. The expert involvement for default limits was for "opinion and confirmation" and "final review," not for adjudicating individual cases on a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The document primarily discusses changes and validation of an existing secondary monitoring system, not its comparative effectiveness against human readers.

6. Standalone Performance

The device is described as a "secondary monitoring" and "secondary alert system." The Indications for Use explicitly state: "Once alerted, you must refer to the primary monitor or device before making a clinical decision." This indicates it's designed to assist human clinicians, not to operate autonomously as a standalone diagnostic tool. Therefore, a standalone performance study in the sense of demonstrating diagnostic accuracy independent of a human is not directly applicable or discussed for decision-making. The "Performance Data" section addresses usability and the clinical validity of its alert thresholds rather than standalone diagnostic performance metrics.

7. Type of Ground Truth Used

Human Factors Study: Ground truth would relate to user task completion and usability issues, not clinical diagnosis.
Default Limits and Thresholds: Based on "Review of References" (published studies), "Expert Committee" opinion/confirmation, and "External Experts" review. This is expert consensus/opinion based on clinical knowledge and literature rather than pathology or outcomes data on a specific patient cohort for device performance evaluation.

8. Sample Size for the Training Set

No training set is mentioned in the context of machine learning. This device appears to be a rule-based or threshold-based system rather than one that employs machine learning requiring a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set for machine learning is described.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 15, 2016

Alertwatch LLC % Donna-Bea Tillman Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street Suite 100 Alexandria, Virginia 22314

Re: K153335

Trade/Device Name: Alertwatch: OR Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: February 16, 2016 Received: February 18, 2016

Dear Donna-Bea Tillman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153335

Device Name AlertWatch: OR

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY - K153335

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the AlertWatch:OR is provided below.

Device Common Name:	Physiological Patient Monitor without arrhythmiadetection or alarms
Device Trade Name:	AlertWatch:OR
Applicant:	AlertWatch, LLC1600 Huron Pkwy, Bldg. 520, Ste. 2326Ann Arbor, MI 48109
Contact:	Justin Adams, CEOAlertWatch, LLCPhone: 734-998-8344Email: Justin.adams@alertwatch.com
Prepared by:	Donna-Bea TillmanSenior ConsultantBiologics Consulting Group, Inc.Phone: 410-531-6542Fax: 720-293-0014Email: dtillman@bcg-usa.com
Date Prepared:	November 18, 2015
Classification Regulation:	21 CFR 870.2300 - Cardiac monitor (includingcardiotachometer and rate alarm)
Panel:	Cardiovascular
Product Code:	MWI
Predicate Device:	K130401, AlertWatch: OR, AlertWatch, LLC

Indication for Use:

AlertWatch:OR is also intended for use by supervising anesthesiologists outside of operating rooms. Once alerted, the supervising anesthesiologist must contact the clinician inside the

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operating room or must return to the operating room before making a clinical decision. Once either clinician is alerted, they must refer to the primary monitor or device before making a clinical decision.

Device Description:

Performance Data:

. Human Factors Study: The iPhone version of AlertWatch:OR has a different user interface than the desktop product. To better understand any potential usability issues that could interfere with the intended use of the product. AlertWatch performed a comprehensive human factors study. The iPad version did not require a human factors study, because the layout and input methodology was the same as the predicate version (assuming a touch screen PC in the operating room).
. Default Limits and Thresholds: AlertWatch, Inc. used a three-phased approach to ensure that the default limits were clinically valid:
- 1. Review of References. AlertWatch sought out definitive published studies that highlighted appropriate limits for certain patient conditions. This includes limits and thresholds for the green/yellow/red organ schema, as well as the alerts and formulae.
- 1. Expert Committee. When references were not available, AlertWatch sought out the opinion and confirmation of anesthesia physicians at the University of Michigan Health System. Each of these clinicians reviewed the limits, provided feedback, and reviewed the final results.
- 1. External Experts. AlertWatch obtained final review of the default limits from an external group of four anesthesiology experts.
IEC 60601-1-8: A summary of how AlertWatch:OR addresses the primary issues identified in IEC 60601-1-8 is provided in the submission.

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Substantial Equivalence:

Primary Predicate -The cleared AlertWatch:OR (K130401) is provided as a primary predicate device in terms of Indications for Use and technological characteristics.

Reference Device - Per the FDA Guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued July 28, 2104, the cleared Amcom CommTech Messenger (K112047) is provided as a reference device to support the use of paging to include alerts that originate from AlertWatch:OR.

The table below compares the key technological features of the subject device to the primary predicate device (AlertWatch: OR K130401).

	Predicate Device	Proposed Device
Device Name	AlertWatch:OR (v2.48)	AlertWatch:OR (v2.50)
510(k) number	K130401	K153335
Classification	MWI	MWI
Regulation	870.2300	870.2300
Indications for Use	AlertWatch:OR is intended for use byclinicians for secondary monitoring ofpatients within operating rooms.AlertWatch:OR combines data fromnetworked physiologic monitors.anesthesia information managementsystems and patient medical recordsand displays them in one place.AlertWatch:OR can only be used withboth physiological monitors and AIMSversions that have been validated byAlertWatch. Once alerted, you mustrefer to the primary monitor or devicebefore making a clinical decision.	AlertWatch:OR is intended for use byclinicians for secondary monitoring ofpatients within operating rooms.AlertWatch:OR combines data fromnetworked physiologic monitors, anesthesiainformation management systems andpatient medical records and displays themin one place. AlertWatch:OR can only beused with both physiological monitors andAIMS versions that have been validated byAlertWatch. Once alerted, you must refer tothe primary monitor or device beforemaking a clinical decision.AlertWatch:OR is also intended for use bysupervising anesthesiologists outside ofoperating rooms. Once alerted, thesupervising anesthesiologist must contactthe clinician inside the operating room ormust return to the operating room beforemaking a clinical decision. Once eitherclinician is alerted, they must refer to theprimary monitor or device before making aclinical decision.
Intended Useenvironment	OR - referred to primary monitor forclinical decision.	OR - referred to primary monitor forclinical decision.The mobile AlertWatch application can beinstalled on a personal iPhone or used viasafari on an iPad for use by supervisinganesthesiologists outside of operatingrooms, who are connected to the hospital
	Predicate Device	Proposed Device
		network.
Intended Users	Anesthesiologist, Resident, CRNA	Identical
Data server	AlertWatch:OR accesses physiologicdata from the hospital network, and allother data from the AIMS databaseserver.	Identical
Supported AIMSsystems	GE Centricity 7.63	Centricity, version 7.6.3Picis / Optum, version 421iMDsoft / Metavision, version 5.46.44
Supported physiologicalmonitors	GE Solar 9500GE Carespan B850	Identical
Hardware platformssupported	PC	PC, iPad, iPhone
Generates clinicaladvisories	AlertWatch:OR Alerts analyzes datafrom patient monitors and othersources and alerts when values exceedpreset limits.	AlertWatch:OR Alerts analyzes data frompatient monitors and other sources andalerts when values exceed preset limits.There are been some changes to the contentof these advisories (see Section 11.9 and11.10)
Re-display of vital signdata from primarymonitors	Yes	Yes
Intended to replaceprimary monitors	No	No
Paging	Yes. For clinicians to page each otherusing the hospital-established pagingsystem.	Yes. For clinicians to page each other andfor AlertWatch:OR to transmit alerts usingthe hospital-established paging system.
Uses color to displayclinical information	Image: Predicate device color display	Image: Proposed device color display

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Substantial Equivalence Conclusion:

The subject AlertWatch:OR (v2.50) is modification of the previously cleared device (K130401) that adds several new features that do not alter the fundamental intended use of the device as a secondary monitor for patients in the operating room. The indications for use are identical to the predicate device.

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The modified alerts and changes to the display of information, and the addition of an iPhone version, do not raise different questions of safety or effectiveness when compared to the primary predicate device. A Usability Study demonstrated that users were able to successfully complete critical tasks in a simulated use environment. Wireless coexistence testing demonstrated that the system could operate correctly in an environment with other wireless devices. Software verification testing demonstrated that the software met all requirements and performed as expected. Therefore, AlertWatch:OR (v2.50) can be found substantially equivalent to the previously cleared AlertWatch:OR (v2.48).

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).